FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
EAGLE VISION-FREEMAN(TM) PUNCTAL VALVE
K Number: K890920
·
Decision Apr 11, 1989
Classifications
1
FEI Numbers
37
Registration Numbers
38
Same Product Code
48
Applicant Total
7
Review Days
47
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Basic Information
- Device Name
- EAGLE VISION-FREEMAN(TM) PUNCTAL VALVE
- K Number
- K890920
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Eagle Vision, Inc.
- Date Received
- February 23, 1989
- Decision Date
- April 11, 1989
- Product Code
- LZU
- Advisory Committee
- Unknown
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LZU | Plug, Punctum | FDA unclassified | Unknown |
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Other Clearances by Eagle Vision, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K053333 | EAGLEVISION GELLANSERTS, MODEL REF 0040 | May 2, 2006 | Substantially Equivalent |
| K030353 | MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS | Apr 25, 2003 | Substantially Equivalent |
| K991130 | FLEXPLUG | Apr 20, 1999 | Substantially Equivalent |
| K905427 | EAGLE VISION FREEMAN RADIOPAGUE PUNCTUM PLUG | Jun 6, 1991 | Substantially Equivalent |
| K890919 | TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT | May 16, 1989 | Substantially Equivalent |
| K883233 | EV MONOCANALICULAR STENT (TM) | Aug 22, 1988 | Substantially Equivalent |